eyeforpharma Medical Affairs USA will bring together global medical leaders to help position this department as a business critical partner. The role of Medical Affairs is changing, and the insights generated at this summit will help shape decisions across your entire organization.

Medical Affairs Disrupted

The evolution of Medical Affairs from focusing on educating HCPs on the science behind medicines to an integrated business unit building two-way relationships with multiple stakeholders has been rapid. Within this much broader remit, a key challenge is funnelling patient insights into company decision making.

At Pfizer, a central hub drives the patient-centricity agenda, but currently that hub is not Medical Affairs. “We wanted to have the hub function cross the entire enterprise,” says Roslyn Schneider, Global Patient Affairs Lead, Pfizer. “While Medical Affairs sits in each of the businesses, it doesn’t cross the entire enterprise from start to end, so we designed Global Patient Affairs as the centralized function, working with all groups to drive patient-centered philosophies and actions. However, Medical Affairs could potentially become the hub because many have the skills and capabilities, or could develop them.”

Medical Affairs is well positioned to drive patient-centric medical information exchange, given that its representatives sit on many review committees. “As Medical reviews all materials to be shared with patients or healthcare professionals, it is in a good position to understand whether patients were involved in their development. Also, Medical traverses many disparate functions – including public affairs, corporate affairs, government affairs – so it has strong connections to colleagues with relationships with patient advocacy groups and is uniquely positioned to partner with them on our shared goals,” says Schneider.

“It’s more important than ever that we have clear guiding principles around how these functions interact and collaborate to ensure it is effective and compliant, while, at the same time, maintaining their independence. It’s important to ensure that everyone has a clear understanding of the role of scientific exchange by someone from Medical Affairs and the role of promotional exchange by Commercial colleagues. Maintaining the integrity and credibility of both functions is essential.”

With so much medical data flowing into Medical Affairs, how should it be structured to enhance agile and compliant information sharing? “One way is by clearly defining roles and responsibilities upfront, to be clear that everyone understands what their remit is,” says Shontelle Dodson, Vice President, Medical Excellence/Medical Affairs Global, Astellas Pharma. “We really encourage collaboration within Astellas; we want groups to exchange relevant information, including informing strategies. However, when it comes to execution, for example developing a protocol or executing a clinical trial, that needs to be done independently by Medical Affairs. At the same time, Medical Affairs needs to understand potential needs and gaps identified by the Commercial organization and the two groups need to be able to share that information. That’s the key to successful collaboration – provide operating principles, along with effective training, to make effective collaborations a reality.”

Where the patient is

As patients take a greater role in their healthcare decisions, actively seeking medical information outside their physicians’ offices, the presentation of this information in a form they can readily understand will expand.

We need to ensure that we’re connected to all the changing expectations within patient involvement, whether that’s patients as advisors or consultants or, in many cases, partners, co-authors, and co-presenters.

Medical is at the forefront, says Schneider. “It’s about trying to meet people where they are, and that could even be watching daytime television. Our Chief Medical Officer appears on some of the daytime televisions shows that may help people take action to prevent disease or talk with their health care teams about their health, treatments and clinical research. These segments have nothing to do with products; at the end of each segment, Dr Freda Lewis-Hall says: “For more information go to gethealthystayhealthy.com”. Medical Affairs colleagues contribute medical expertise to that site to ensure that in fact there is more information there.”

“Another way that we to respond to people in a timely fashion is via the almost two million inquiries we receive each year through our Medical Information group,” she adds. “In addition to responding to the specific question we analyze these inquiries for learnings. We proactively look for ways to better meet the information needs of patients and their health care teams.”

How will Medical Affairs evolve to address patient needs? “Medical encompasses the basic tenet of the medical professional around lifelong learning. Part of how MA needs to evolve is to continue to hone not only its medical expertise but listening skills and empathy and to respect the patient community as experts. We need to ensure that we’re connected to all the changing expectations within patient involvement, whether that’s patients as advisors or consultants or, in many cases, partners, co-authors, and co-presenters,” says Schneider.

Working with patient organizations to gather data in a manner that is compliant and sensitive to patient concerns for privacy is an essential element of MA’s evolution, she adds. “Ideally, we would include patient community input to understand which data are important and should be gathered. Medical Affairs should be part of the groups that are developing guidance internally and externally and we can engage with other functional experts internally. Here we have separate groups that are accountable for patient-centered outcomes assessments, value assessments and who work with real world data and are advancing patient preference studies. Understanding how these functional experts weave their work together into the overall picture is something that Medical Affairs is and should be a part of to make this a more patient-centered process.”